Sterility Assurance Specialist

2 months ago


Liverpool, United Kingdom Seqirus Full time

**Responsibilities**:

- Under general supervision, provides support on Quality systems to ensure compliance with company standards and GMP regulatory guidelines
- Develops, maintains and improves GMP-related quality control systems including standard operating procedures (SOPs)
- Supports quality systems related to Validation, LIMS, Calibration, Document Management, Deviation Management, CAPA, Change Control, and Enterprise Learning Management
- Collects, collates, evaluates, and reports on Quality performance data of assigned business areas
- Conducts internal audits and assists with 3rd party supplier audits; implements continuous improvement projects
- Collaborates to resolve technical issues, provide quality training and communicate best practices

**Qualifications**:

- Bachelor degree in Engineering, Business or a relevant scientific discipline (Chemistry, Biology, Microbiology, etc.)
- Proven quality systems experience in pharmaceutical manufacturing/cGMP regulated environment
- Knowledge of current Good Manufacturing Practices (cGMP)
- Knowledge of FDA and EMA requirements
- Knowledge / experience of sterile environments

**Our Benefits**:
CSL Seqirus is committed to attracting and retaining world-class employees who are valued for their contributions to achieving business objectives. Learn more about some of the benefits you can participate in when you join CSL Seqirus.

**About CSL Seqirus**:
**CSL Seqirus is part of CSL Limited (ASX: CSL). As one of the largest influenza vaccine providers in the world, CSL Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. Learn more about CSL **Seqirus**.**:
**We want Seqirus to reflect the world around us**:
As a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL Seqirus.

**Do work that matters at CSL Seqirus**:
**Watch our ‘On the Front Line’ video to learn more about CSL Seqirus



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